NCT00799656

Brief Summary

The primary objective of this study is to assess the efficacy of ataciguat versus placebo in reducing pain intensity in patients with neuropathic pain. The secondary objective is to assess the safety and tolerability of ataciguat versus placebo.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for phase_2 pain

Timeline
Completed

Started Nov 2008

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

November 27, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 1, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

April 1, 2011

Status Verified

March 1, 2011

Enrollment Period

7 months

First QC Date

November 27, 2008

Last Update Submit

March 31, 2011

Conditions

Pain

Keywords

Diabetic neuropathypainful painpostoperative

Outcome Measures

Primary Outcomes (1)

  • Change in average daily pain intensity

    after 28-days treatment

Secondary Outcomes (3)

  • Responder rate

    after 28-days treatment

  • Rescue medication intake

    during 28-days treatment

  • Change in Neuropathic Pain Symptom Inventory (NPSI)

    after 28-days treatment

Study Arms (2)

1

EXPERIMENTAL

First period: Ataciguat - Second period: Placebo

Drug: ataciguat (HMR1766)Drug: placebo

2

EXPERIMENTAL

First period: Placebo - Second period: Ataciguat

Drug: ataciguat (HMR1766)Drug: placebo

Interventions

ataciguat (HMR1766)DRUG

oral administration 200mg once daily for 28 days

12
placeboDRUG

oral administration once daily for 28 days

12

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with chronic neuropathic pain due to diabetic polyneuropathy or a nerve lesion following surgery. The pain must be present for more than 3 months.

You may not qualify if:

  • Presence or history of cancer within the past five years
  • Patients with a history of HIV infection
  • Patients with active hepatitis B or C
  • Patients with any pain other than the neuropathic pain of greater or equal severity
  • Patients with a diabetes mellitus for less than 6 months
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Sanofi-Aventis Administrative Office

Vienna, Austria

Location

Sanofi-Aventis Administrative Office

Prague, Czechia

Location

Sanofi-Aventis Administrative Office

Bucharest, Romania

Location

MeSH Terms

Conditions

PainDiabetic Neuropathies

Interventions

5-chloro-2-(5-chlorothiophene-2-sulfonylamino)-N-(4-(morpholine-4-sulfonyl)phenyl)benzamide

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • Hans-Goerg Kress, Professor

    Medizinische Universität / AKH Wien - Währinger Gürtel 18-20 - A-1090 Wien

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 27, 2008

First Posted

December 1, 2008

Study Start

November 1, 2008

Primary Completion

June 1, 2009

Study Completion

September 1, 2009

Last Updated

April 1, 2011

Record last verified: 2011-03

Locations

CZ(1)AU(1)RO(1)